Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
概览
- 阶段
- 不适用
- 干预措施
- Hydra transcatheter aortic valve (THV) series
- 疾病 / 适应症
- Aortic Valve Stenosis
- 发起方
- Sahajanand Medical Technologies Limited
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Primary safety endpoint
- 状态
- 招募中
- 最后更新
- 5天前
概览
简要总结
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.
The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.
详细描述
This is a prospective, observational, multi-centre study. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the efficacy and safety of the Hydra THV series (Vascular Innovations Co. Ltd., Nonthaburi, Thailand). Additionally, the study will conduct the following evaluation: 1. The remote ambulatory cardiac monitoring (rACM) using the Checkpoint Cardio System, consisting of 72 hours of continuous electrocardiogram (ECG) monitoring, will be evaluated post hospital discharge where it is clinically appropriate. 2. Coronary access will be evaluated immediately post-TAVI by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. This will be done in a sub-set of patients who are either known to have coronary artery disease, did not have coronary angiogram prior to TAVI or where it is felt to be clinically appropriate for other reasons post implant. Following discharge, clinical follow-ups are scheduled at 45 days (±14 days), and 1-year (±30 days).
研究者
入排标准
入选标准
- •Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- •Full understanding and willing to provide informed consent to study enrolment
- •Age ≥ 18 years
排除标准
- •Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- •Refusal to provide informed consent to study enrolment
- •Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- •Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.
研究组 & 干预措施
Severe aortic valve stenosis
Hydra transcatheter aortic valve (THV) series
干预措施: Hydra transcatheter aortic valve (THV) series
结局指标
主要结局
Primary safety endpoint
时间窗: 45 days
Early safety as defined by VARC-3 as composite of: * Freedom from all-cause mortality; * Freedom from all stroke; * Freedom from VARC 3 type 3-4 bleeding; * Freedom from major vascular, access-related, or cardiac structural complication; * Freedom from acute kidney injury stage 3 or 4; * Freedom from moderate or severe aortic regurgitation; * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; * Freedom from surgery or intervention related to the device.
Primary performance endpoint
时间窗: 45 days
Device success as defined by VARC-3 as composite of: * Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
次要结局
- Coronary artery obstruction requiring intervention(45 days, and 1-year)
- Technical success(Immediately after the procedure)
- Disabling stroke(45 days, and 1-year)
- Myocardial infarction(45 days, and 1-year)
- Major vascular complication(45 days)
- Acute kidney injury(45 days)
- New permanent pacemaker implantation due to procedure related conduction abnormalities(45 days, and 1-year)
- Cardiovascular mortality(45 days, and 1-year)
- All-cause mortality(45 days, and 1-year)
- All stroke(45 days, and 1-year)
- Re-hospitalization for procedure- or valve-related causes(45 days, and 1-year)
- Mean aortic valve gradient(45 days, and 1-year)
- Effective Orifice Area (EOA)(45 days, and 1-year)
- Paravalvular leak(45 days, and 1-year)
- New-onset atrial fibrillation(45 days, and 1-year)
- New York Heart Association (NYHA) functional class(45 days, and 1-year)
- Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(45 days, and 1-year)
- Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration(45 days, and 1-year)
- Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis(45 days, and 1-year)
- Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)(45 days, and 1-year)
- VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)(45 days, and 1-year)
- Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI)(72 hours post hospital discharge)
- Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia(Immediately post-TAVI)